Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set— 510(k) K242504
Substantially EquivalentPerfuze, Ltd.
FDA 510(k) clearance K242504 for Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set, Substantially Equivalent on 2024-09-20. Applicant: Perfuze, Ltd.. Device class: 2.
Clearance details
- Applicant
- Perfuze, Ltd.
- Product code
- Product code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Galway, IE
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More clearances from Perfuze, Ltd.
view allAdverse events under product code NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.